81220 Federal Register / Vol. 80, No. 249 / Tuesday, December 29, 2015 / Proposed Rules 

and in accordance with the instructions of 

Section 4.2.2, ‘‘Inspection Requirements,’’ of 

Airbus AOT A71L005–14, Revision 01, dated 

December 11, 2014. 

(2) If, during the torque check required by 

paragraph (k)(1) of this AD, any discrepancy 

is detected (one bolt rotates, two or more 

bolts rotate, or one or more bolts are fully 

broken): Within the compliance time 

specified in Airbus AOT A71L005–14, 

Revision 01, dated December 11, 2014, 

accomplish all applicable corrective actions 

in accordance with the instructions of 

Section 4.2.3, ‘‘Findings,’’ of Airbus AOT 

A71L005–14, Revision 01, dated December 

11, 2014, except as required by paragraphs 

(m)(1) and (m)(2) of this AD. 

(l) Action for Airbus Model A340–541 and 

–642 Airplanes Equipped With Rolls-Royce 

Trent 500 Engines 

(1) For Airbus Model A340–541 and –642 

airplanes equipped with Rolls-Royce Trent 

500 Engines: Within 2,000 flight hours after 

the effective date of this AD, accomplish a 

one-time torque check of FWD and AFT 

engine mount bolts on each affected engine, 

at the locations specified in, and in 

accordance with the instructions of Section 

4.2.2, ‘‘Inspection requirements,’’ of Airbus 

AOT A71L008–14, Revision 01, dated 

December 18, 2014. 

(2) If, during the torque check required by 

paragraph (l)(1) of this AD, any discrepancy 

is detected (one bolt rotates, two or more 

bolts rotate, or one or more bolts are fully 

broken): Within the compliance time 

specified in Airbus AOT A71L008–14, 

Revision 01, dated December 18, 2014, 

accomplish all applicable corrective actions, 

in accordance with the instructions of 

Section 4.2.3, ‘‘Findings,’’ of Airbus AOT 

A71L008–14, Revision 01, dated December 

18, 2014, except as required by paragraphs 

(m)(1) and (m)(2) of this AD. 

(m) Service Information Exceptions 

(1) Where Airbus AOTs A71L005–14, 

Revision 01, dated December 11, 2014; 

A71L006–14, dated July 22, 2014; and 

A71L008–14, dated September 29, 2014, 

specify to contact Airbus for further actions, 

before further flight, repair using a method 

approved by the Manager, International 

Branch, ANM–116, Transport Airplane 

Directorate, FAA; or the European Aviation 

Safety Agency (EASA); or Airbus’s EASA 

Design Organization Approval (DOA). 

(2) Where Airbus AOT A71L004–14, 

Revision 01, dated April 7, 2014; AOT 

A71L005–14, Revision 01, dated December 

11, 2014; AOT A71L006–14, dated July 22, 

2014; and AOT A71L008–14, Revision 01, 

dated December 18, 2014, specify actions ‘‘if 

one pylon bolt fully broken,’’ this AD 

requires that those actions be done if one or 

more pylon bolt is found fully broken during 

any torque check required by paragraph 

(h)(1), (j)(1), (k)(1) or (l)(1) of this AD. 

(n) Reporting 

At the applicable time specified in 

paragraphs (n)(1) and (n)(2) of this AD: After 

accomplishment of any torque check 

required by paragraphs (h), (j), (k), and (l) of 

this AD, report all inspection results to 

Airbus, including no findings, in accordance 

with the ‘‘Reporting’’ section of the 

applicable service information specified in 

paragraphs (h), (j), (k), and (l) of this AD. 

(1) If the torque check was done on or after 

the effective date of this AD: Submit the 

report within 30 days after the torque check. 

(2) If the torque check was done before the 

effective date of this AD: Submit the report 

within 30 days after the effective date of this 

AD. 

(o) Credit for Previous Actions 

(1) This paragraph provides credit for the 

actions required by paragraph (h) of this AD, 

if those actions were performed before the 

effective date of this AD using Airbus AOT 

A71L004–14, dated April 1, 2014 (for Airbus 

Model A330 Airplanes Equipped with Pratt 

and Whitney Engines), which is not 

incorporated by reference in this AD. 

(2) This paragraph provides credit for the 

actions required by paragraph (k) of this AD, 

if those actions were performed before the 

effective date of this AD using Airbus AOT 

A71L005–14, dated September 29, 2014 (for 

Airbus Model A330 Airplanes Equipped with 

Rolls-Royce Trent 700 Engines), which is not 

incorporated by reference in this AD. 

(3) This paragraph provides credit for the 

actions required by paragraph (l) of this AD, 

if those actions were performed before the 

effective date of this AD using Airbus AOT 

A71L008–14, dated September 29, 2014 (for 

Airbus Model A340 Airplanes Equipped with 

Rolls-Royce Trent 500 Engines), which is not 

incorporated by reference in this AD. 

(p) Other FAA AD Provisions 

The following provisions also apply to this 

AD: 

(1) Alternative Methods of Compliance 

(AMOCs): The Manager, International 

Branch, ANM–116, Transport Airplane 

Directorate, FAA, has the authority to 

approve AMOCs for this AD, if requested 

using the procedures found in 14 CFR 39.19. 

In accordance with 14 CFR 39.19, send your 

request to your principal inspector or local 

Flight Standards District Office, as 

appropriate. If sending information directly 

to the International Branch, send it to ATTN: 

Vladimir Ulyanov, Aerospace Engineer, 

International Branch, ANM–116, Transport 

Airplane Directorate, FAA 1601 Lind Avenue 

SW., Renton, WA 98057–3356; telephone 

425–227–1138; fax 425–227–1149. 

Information may be emailed to: 9-ANM-116- 

AMOC-REQUESTS@faa.gov. Before using 

any approved AMOC, notify your appropriate 

principal inspector, or lacking a principal 

inspector, the manager of the local flight 

standards district office/certificate holding 

district office. The AMOC approval letter 

must specifically reference this AD. 

(2) Contacting the Manufacturer: For any 

requirement in this AD to obtain corrective 

actions from a manufacturer, the action must 

be accomplished using a method approved 

by the Manager, International Branch, ANM– 

116, Transport Airplane Directorate, FAA; or 

the European Aviation Safety Agency 

(EASA); or Airbus’s EASA Design 

Organization Approval (DOA). If approved by 

the DOA, the approval must include the 

DOA-authorized signature. 

(3) Reporting Requirements: A federal 

agency may not conduct or sponsor, and a 

person is not required to respond to, nor 

shall a person be subject to a penalty for 

failure to comply with a collection of 

information subject to the requirements of 

the Paperwork Reduction Act unless that 

collection of information displays a current 

valid OMB Control Number. The OMB 

Control Number for this information 

collection is 2120–0056. Public reporting for 

this collection of information is estimated to 

be approximately 5 minutes per response, 

including the time for reviewing instructions, 

completing and reviewing the collection of 

information. All responses to this collection 

of information are mandatory. Comments 

concerning the accuracy of this burden and 

suggestions for reducing the burden should 

be directed to the FAA at: 800 Independence 

Ave. SW., Washington, DC 20591, Attn: 

Information Collection Clearance Officer, 

AES–200. 

(q) Related Information 

(1) Refer to Mandatory Continuing 

Airworthiness Information (MCAI) EASA 

Airworthiness Directive 2015–0082, dated 

May 11, 2015, for related information. This 

MCAI may be found in the AD docket on the 

Internet at http://www.regulations.gov by 

searching for and locating Docket No. FAA– 

2015–7533. 

(2) For service information identified in 

this AD, contact Airbus SAS, Airworthiness 

Office—EAL, 1 Rond Point Maurice Bellonte, 

31707 Blagnac Cedex, France; telephone +33 

5 61 93 36 96; fax +33 5 61 93 45 80; email 

airworthiness.A330-A340@airbus.com; 

Internet http://www.airbus.com. You may 

view this service information at the FAA, 

Transport Airplane Directorate, 1601 Lind 

Avenue SW., Renton, WA. For information 

on the availability of this material at the 

FAA, call 425–227–1221. 

Issued in Renton, Washington, on 

December 18, 2015. 

Jeffrey E. Duven, 

Manager, Transport Airplane Directorate, 

Aircraft Certification Service. 

[FR Doc. 2015–32547 Filed 12–28–15; 8:45 am] 

BILLING CODE 4910–13–P 

DEPARTMENT OF TRANSPORTATION 

Federal Aviation Administration 

14 CFR Part 39 

[Docket No. FAA–2015–7531; Directorate 

Identifier 2015–NM–052–AD] 

RIN 2120–AA64 

Airworthiness Directives; The Boeing 

Company Airplanes 

AGENCY: Federal Aviation 

Administration (FAA), DOT. 

ACTION: Notice of proposed rulemaking 

(NPRM). 

SUMMARY: We propose to adopt a new 

airworthiness directive (AD) for certain 

The Boeing Company Model 787–8 

airplanes. This proposed AD was 


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prompted by reports of electrical shorts 

of the motor stator wiring burning a hole 

through the housing of the motor of the 

cabin air compressor (CAC). This 

proposed AD would require installing 

modified inboard and outboard CAC 

modules on the left side and right side 

cabin air conditioning and temperature 

control system (CACTCS) packs. We are 

proposing this AD to prevent an 

electrical short from burning through 

the housing of the motor of the CAC, 

which could result in a fire in the pack 

bay, and consequent reduced 

controllability of the airplane. 

DATES: We must receive comments on 

this proposed AD by February 12, 2016. 

ADDRESSES: You may send comments, 

using the procedures found in 14 CFR 

11.43 and 11.45, by any of the following 

methods: 

• Federal eRulemaking Portal: Go to 

http://www.regulations.gov. Follow the 

instructions for submitting comments. 

• Fax: 202–493–2251. 

• Mail: U.S. Department of 

Transportation, Docket Operations, M– 

30, West Building Ground Floor, Room 

W12–140, 1200 New Jersey Avenue SE., 

Washington, DC 20590. 

• Hand Delivery: Deliver to Mail 

address above between 9 a.m. and 5 

p.m., Monday through Friday, except 

Federal holidays. 

For Boeing service information 

identified in this proposed AD, contact 

Boeing Commercial Airplanes, 

Attention: Data & Services Management, 

P. O. Box 3707, MC 2H–65, Seattle, WA 

98124–2207; telephone 206–544–5000, 

extension 1; fax 206–766–5680; Internet 

https://www.myboeingfleet.com. 

You may view this referenced service 

information at the FAA, FAA, Transport 

Airplane Directorate, 1601 Lind Avenue 

SW., Renton, WA. For information on 

the availability of this material at the 

FAA, call 425–227–1221. 

Examining the AD Docket 

You may examine the AD docket on 

the Internet at http://

www.regulations.gov by searching for 

and locating Docket No. FAA–2015– 

7531; or in person at the Docket 

Management Facility between 9 a.m. 

and 5 p.m., Monday through Friday, 

except Federal holidays. The AD docket 

contains this proposed AD, the 

regulatory evaluation, any comments 

received, and other information. The 

street address for the Docket Office 

(phone: 800–647–5527) is in the 

ADDRESSES section. Comments will be 

available in the AD docket shortly after 

receipt. 

FOR FURTHER INFORMATION CONTACT: Eric 

Brown, Aerospace Engineer, Cabin 

Safety and Environmental Systems 

Branch, ANM–150S, FAA, Seattle 

Aircraft Certification Office (ACO), 1601 

Lind Avenue SW., Renton, WA 98057– 

3356; phone: 425–917–6476; fax: 425– 

917–6590; email: eric.m.brown@faa.gov. 

SUPPLEMENTARY INFORMATION: 

Comments Invited 

We invite you to send any written 

relevant data, views, or arguments about 

this proposal. Send your comments to 

an address listed under the ADDRESSES

section. Include ‘‘Docket No. FAA– 

2015–7531; Directorate Identifier 2015– 

NM–052–AD’’ at the beginning of your 

comments. We specifically invite 

comments on the overall regulatory, 

economic, environmental, and energy 

aspects of this proposed AD. We will 

consider all comments received by the 

closing date and may amend this 

proposed AD because of those 

comments. 

We will post all comments we 

receive, without change, to http://

www.regulations.gov, including any 

personal information you provide. We 

will also post a report summarizing each 

substantive verbal contact we receive 

about this proposed AD. 

Discussion 

We received reports of electrical 

shorts of the motor stator wiring burning 

a hole through the housing of the motor 

of the CAC. The pack bay is classified 

as a flammable fluid leakage zone and 

the burn-through would be classified as 

an ignition source. This condition, if not 

corrected, could result in a fire in the 

pack bay, and consequent reduced 

controllability of the airplane. 

Related Service Information Under 1 

CFR Part 51 

We reviewed Boeing Alert Service 

Bulletin B787–81205–SB210055–00, 

Issue 001, dated March 12, 2015. This 

service information describes 

procedures for installing modified 

inboard and outboard CAC modules on 

the left side and right side CACTCS 

packs. This service information is 

reasonably available because the 

interested parties have access to it 

through their normal course of business 

or by the means identified in the 

ADDRESSES section of this NPRM. 

FAA’s Determination 

We are proposing this AD because we 

evaluated all the relevant information 

and determined the unsafe condition 

described previously is likely to exist or 

develop in other products of the same 

type design. 

Proposed AD Requirements 

This proposed AD would require 

accomplishing the actions specified in 

the service information described 

previously. For information on the 

procedures and compliance times, see 

this service information at http://

www.regulations.gov by searching for 

and locating Docket No. FAA–2015– 

7531. 

Explanation of Required for 

Compliance (RC) Steps in Service 

Information 

The FAA worked in conjunction with 

industry, under the Airworthiness 

Directive Implementation Aviation 

Rulemaking Committee (ARC), to 

enhance the AD system. One 

enhancement was a new process for 

annotating which steps in the service 

information are required for compliance 

with an AD. Differentiating these steps 

from other tasks in the service 

information is expected to improve an 

owner’s/operator’s understanding of 

crucial AD requirements and help 

provide consistent judgment in AD 

compliance. The steps identified as RC 

in any service information identified 

previously have a direct effect on 

detecting, preventing, resolving, or 

eliminating an identified unsafe 

condition. 

For service information that contains 

steps that are labeled as RC, the 

following provisions apply: (1) the steps 

labeled as RC, including substeps under 

an RC step and any figures identified in 

an RC step, must be done to comply 

with the AD, and an AMOC is required 

for any deviations to RC steps, including 

substeps and identified figures; and (2) 

steps not labeled as RC may be deviated 

from using accepted methods in 

accordance with the operator’s 

maintenance or inspection program 

without obtaining approval of an 

AMOC, provided the RC steps, 

including substeps and identified 

figures, can still be done as specified, 

and the airplane can be put back in an 

airworthy condition. 

Costs of Compliance 

We estimate that this proposed AD 

affects 22 airplanes of U.S. registry. 

We estimate the following costs to 

comply with this proposed AD: 


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81222 Federal Register / Vol. 80, No. 249 / Tuesday, December 29, 2015 / Proposed Rules 

ESTIMATED COSTS

Action Labor cost Parts cost Cost per product Cost on U.S. operators 

Modification, installation, 

and installation test.

Up to 30 work-hours × $85 per hour = $2,550 ...... $0 Up to $2,550 .................. Up to $56,100. 

According to the manufacturer, some 

of the costs of this proposed AD may be 

covered under warranty, thereby 

reducing the cost impact on affected 

individuals. We do not control warranty 

coverage for affected individuals. As a 

result, we have included all costs in our 

cost estimate. 

Authority for This Rulemaking 

Title 49 of the United States Code 

specifies the FAA’s authority to issue 

rules on aviation safety. Subtitle I, 

section 106, describes the authority of 

the FAA Administrator. Subtitle VII: 

Aviation Programs, describes in more 

detail the scope of the Agency’s 

authority. 

We are issuing this rulemaking under 

the authority described in Subtitle VII, 

Part A, Subpart III, Section 44701: 

‘‘General requirements.’’ Under that 

section, Congress charges the FAA with 

promoting safe flight of civil aircraft in 

air commerce by prescribing regulations 

for practices, methods, and procedures 

the Administrator finds necessary for 

safety in air commerce. This regulation 

is within the scope of that authority 

because it addresses an unsafe condition 

that is likely to exist or develop on 

products identified in this rulemaking 

action. 

Regulatory Findings 

We determined that this proposed AD 

would not have federalism implications 

under Executive Order 13132. This 

proposed AD would not have a 

substantial direct effect on the States, on 

the relationship between the national 

Government and the States, or on the 

distribution of power and 

responsibilities among the various 

levels of government. 

For the reasons discussed above, I 

certify this proposed regulation: 

(1) Is not a ‘‘significant regulatory 

action’’ under Executive Order 12866, 

(2) Is not a ‘‘significant rule’’ under 

the DOT Regulatory Policies and 

Procedures (44 FR 11034, February 26, 

1979), 

(3) Will not affect intrastate aviation 

in Alaska, and 

(4) Will not have a significant 

economic impact, positive or negative, 

on a substantial number of small entities 

under the criteria of the Regulatory 

Flexibility Act. 

List of Subjects in 14 CFR Part 39 

Air transportation, Aircraft, Aviation 

safety, Incorporation by reference, 

Safety. 

The Proposed Amendment 

Accordingly, under the authority 

delegated to me by the Administrator, 

the FAA proposes to amend 14 CFR part 

39 as follows: 

PART 39—AIRWORTHINESS 

DIRECTIVES 

■ 1. The authority citation for part 39 

continues to read as follows: 

Authority: 49 U.S.C. 106(g), 40113, 44701. 

§ 39.13 [Amended] 

■ 2. The FAA amends § 39.13 by adding 

the following new airworthiness 

directive (AD): 

The Boeing Company: Docket No. FAA– 

2015–7531; Directorate Identifier 2015– 

NM–052–AD. 

(a) Comments Due Date 

We must receive comments by February 

12, 2016. 

(b) Affected ADs 

None. 

(c) Applicability 

This AD applies to The Boeing Company 

Model 787–8 airplanes, certificated in any 

category, as identified in Boeing Alert 

Service Bulletin B787–81205–SB210055–00, 

Issue 001, dated March 12, 2015. 

(d) Subject 

Air Transport Association (ATA) of 

America Code 21, Air conditioning. 

(e) Unsafe Condition 

This AD was prompted by reports of 

electrical shorts of the motor stator wiring 

burning a hole through the housing of the 

motor of the cabin air compressor (CAC). We 

are issuing this AD to prevent an electrical 

short from burning through the housing of 

the motor of the CAC, which could result in 

a fire in the pack bay and consequent 

reduced controllability of the airplane. 

(f) Compliance 

Comply with this AD within the 

compliance times specified, unless already 

done. 

(g) Replacement of CAC Modules 

Within 5 years after the effective date of 

this AD, install modified inboard and 

outboard CAC modules on the left side and 

right side cabin air conditioning and 

temperature control system (CACTCS) packs, 

in accordance with the Accomplishment 

Instructions of Boeing Alert Service Bulletin 

B787–81205–SB210055–00, Issue 001, dated 

March 12, 2015. 

(h) Alternative Methods of Compliance 

(AMOCs) 

(1) The Manager, Seattle Aircraft 

Certification Office (ACO), FAA, has the 

authority to approve AMOCs for this AD, if 

requested using the procedures found in 14 

CFR 39.19. In accordance with 14 CFR 39.19, 

send your request to your principal inspector 

or local Flight Standards District Office, as 

appropriate. If sending information directly 

to the manager of the ACO, send it to the 

attention of the person identified in 

paragraph (i)(1) of this AD. Information may 

be emailed to: 9-ANM-Seattle-ACO-AMOCRequests@faa.gov. 

(2) Before using any approved AMOC, 

notify your appropriate principal inspector, 

or lacking a principal inspector, the manager 

of the local flight standards district office/

certificate holding district office. 

(3) An AMOC that provides an acceptable 

level of safety may be used for any repair, 

modification, or alteration required by this 

AD if it is approved by the Boeing 

Commercial Airplanes Organization 

Designation Authorization (ODA) that has 

been authorized by the Manager, Seattle 

ACO, to make those findings. For a repair 

method to be approved, the repair method, 

modification deviation, or alteration 

deviation must meet the certification basis of 

the airplane, and the approval must 

specifically refer to this AD. 

(4) For service information that contains 

steps that are labeled as Required for 

Compliance (RC), the provisions of 

paragraphs (h)(4)(i) and (h)(4)(ii) of this AD 

apply. 

(i) The steps labeled as RC, including 

substeps under an RC step and any figures 

identified in an RC step, must be done to 

comply with the AD. An AMOC is required 

for any deviations to RC steps, including 

substeps and identified figures. 

(ii) Steps not labeled as RC may be 

deviated from using accepted methods in 

accordance with the operator’s maintenance 

or inspection program without obtaining 

approval of an AMOC, provided the RC steps, 

including substeps and identified figures, can 

still be done as specified, and the airplane 

can be put back in an airworthy condition. 

(i) Related Information 

(1) For more information about this AD, 

contact Eric Brown, Aerospace Engineer, 

Cabin Safety and Environmental Systems 

Branch, ANM–150S, FAA, Seattle Aircraft 

Certification Office (ACO), 1601 Lind Avenue 

SW., Renton, WA 98057–3356; phone: 425– 

917–6476; fax: 425–917–6590; email: 

eric.m.brown@faa.gov. 


jstallworth on DSK7TPTVN1PROD with PROPOSALS
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(2) For Boeing service information 

identified in this AD, contact Boeing 

Commercial Airplanes, Attention: Data & 

Services Management, P.O. Box 3707, MC 

2H–65, Seattle, WA 98124–2207; telephone 

206–544–5000, extension 1; fax 206–766– 

5680; Internet https://

www.myboeingfleet.com. You may view this 

referenced service information at the FAA, 

Transport Airplane Directorate, 1601 Lind 

Avenue SW., Renton, Washington. For 

information on the availability of this 

material at the FAA, call 425–227–1221. 

Issued in Renton, Washington, on 

December 18, 2015. 

Jeffrey E. Duven, 

Manager, Transport Airplane Directorate, 

Aircraft Certification Service. 

[FR Doc. 2015–32548 Filed 12–28–15; 8:45 am] 

BILLING CODE 4910–13–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

21 CFR Part 882 

[Docket No. FDA–2014–N–1210] 

Neurological Devices; Reclassification 

of Electroconvulsive Therapy Devices 

Intended for Use in Treating Severe 

Major Depressive Episode in Patients 

18 Years of Age and Older Who Are 

Treatment Resistant or Require a 

Rapid Response; Effective Date of 

Requirement for Premarket Approval 

for Electroconvulsive Therapy for 

Certain Specified Intended Uses 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Proposed order. 

SUMMARY: The Food and Drug 

Administration (FDA) is issuing a 

proposed administrative order to 

reclassify the electroconvulsive therapy 

(ECT) device for use in treating severe 

major depressive episode (MDE) 

associated with major depressive 

disorder (MDD) or bipolar disorder 

(BPD) in patients 18 years of age and 

older who are treatment-resistant or 

who require a rapid response due to the 

severity of their psychiatric or medical 

condition, which is a preamendments 

class III device, into class II (special 

controls) based on new information. 

FDA is also proposing to require the 

filing of a premarket approval 

application (PMA) or a notice of 

completion of a product development 

protocol (PDP) for ECT devices for other 

intended uses specified in this proposed 

order. The Agency is also summarizing 

its proposed findings regarding the 

degree of risk of illness or injury 

designed to be eliminated or reduced by 

requiring the devices to meet the 

statute’s approval requirements for other 

intended uses specified in this proposed 

order. In addition, FDA is announcing 

the opportunity for interested persons to 

request that the Agency change the 

classification of any of the devices 

mentioned in this document based on 

new information. This action 

implements certain statutory 

requirements. 

DATES: Submit either electronic or 

written comments on this proposed 

order by March 28, 2016. See section 

XVII of this document for the proposed 

effective date of a final order based on 

this proposed order. 

ADDRESSES: You may submit comments 

as follows: 

Electronic Submissions 

Submit electronic comments in the 

following way: 

• Federal eRulemaking Portal: http:// 

www.regulations.gov. Follow the 

instructions for submitting comments. 

Comments submitted electronically, 

including attachments, to http://

www.regulations.gov will be posted to 

the docket unchanged. Because your 

comment will be made public, you are 

solely responsible for ensuring that your 

comment does not include any 

confidential information that you or a 

third party may not wish to be posted, 

such as medical information, your or 

anyone else’s Social Security number, or 

confidential business information, such 

as a manufacturing process. Please note 

that if you include your name, contact 

information, or other information that 

identifies you in the body of your 

comments, that information will be 

posted on http://www.regulations.gov. 

• If you want to submit a comment 

with confidential information that you 

do not wish to be made available to the 

public, submit the comment as a 

written/paper submission and in the 

manner detailed (see ‘‘Written/Paper 

Submissions’’ and ‘‘Instructions’’). 

Written/Paper Submissions 

Submit written/paper submissions as 

follows: 

• Mail/Hand delivery/Courier (for 

written/paper submissions): Division of 

Dockets Management (HFA–305), Food 

and Drug Administration, 5630 Fishers 

Lane, Rm. 1061, Rockville, MD 20852. 

• For written/paper comments 

submitted to the Division of Dockets 

Management, FDA will post your 

comment, as well as any attachments, 

except for information submitted, 

marked and identified, as confidential, 

if submitted as detailed in 

‘‘Instructions.’’ 

Instructions: All submissions received 

must include the Docket No. 2014–N– 

1210 for ‘‘Neurological Devices; 

Reclassification of Electroconvulsive 

Therapy Devices Intended for Use in 

Treating Severe Major Depressive 

Episode in Patients 18 Years of Age and 

Older Who Are Treatment-Resistant or 

Require a Rapid Response; Effective 

Date of Requirement for Premarket 

Approval for Electroconvulsive Therapy 

Devices for Certain Specified Intended 

Uses’’. Received comments will be 

placed in the docket and, except for 

those submitted as ‘‘Confidential 

Submissions,’’ publicly viewable at 

http://www.regulations.gov or at the 

Division of Dockets Management 

between 9 a.m. and 4 p.m., Monday 

through Friday. 

• Confidential Submissions—To 

submit a comment with confidential 

information that you do not wish to be 

made publicly available, submit your 

comments only as a written/paper 

submission. You should submit two 

copies total. One copy will include the 

information you claim to be confidential 

with a heading or cover note that states 

‘‘THIS DOCUMENT CONTAINS 

CONFIDENTIAL INFORMATION’’. The 

Agency will review this copy, including 

the claimed confidential information, in 

its consideration of comments. The 

second copy, which will have the 

claimed confidential information 

redacted/blacked out, will be available 

for public viewing and posted on http:// 

www.regulations.gov. Submit both 

copies to the Division of Dockets 

Management. If you do not wish your 

name and contact information to be 

made publicly available, you can 

provide this information on the cover 

sheet and not in the body of your 

comments and you must identify this 

information as ‘‘confidential.’’ Any 

information marked as ‘‘confidential’’ 

will not be disclosed except in 

accordance with 21 CFR 10.20 and other 

applicable disclosure law. For more 

information about FDA’s posting of 

comments to public dockets, see 80 FR 

56469, September 18, 2015, or access 

the information at: http://www.fda.gov/ 

regulatoryinformation/dockets/

default.htm. 

Docket: For access to the docket to 

read background documents or the 

electronic and written/paper comments 

received, go to http://

www.regulations.gov and insert the 

docket number, found in brackets in the 

heading of this document, into the 

‘‘Search’’ box and follow the prompts 

and/or go to the Division of Dockets 

Management, 5630 Fishers Lane, Rm. 

1061, Rockville, MD 20852. 

FOR FURTHER INFORMATION CONTACT: 

Michael J. Ryan, Center for Devices and 


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